Clinical Research Directory
Browse clinical research sites, groups, and studies.
Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
Sponsor: Fundación EPIC
Summary
The VIVALL-2 study is a randomized trial to compare the self-expandable supra-annular Allegra and the balloon-expandable intra-annular Edwards transcatheter valve systems in patients with degenerated biological aortic surgical valve.
Official title: Clinical Trial of the Results of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
104
Start Date
2024-02-01
Completion Date
2026-11-01
Last Updated
2025-12-19
Healthy Volunteers
No
Interventions
NVT ALLEGRA TAVI System TF
Transcatheter aortic valve implantation of a NVT ALLEGRA TAVI System TF in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically
EDWARDS SAPIEN 3 or SAPIEN ULTRA SYSTEM
Transcatheter aortic valve implantation of an EDWARDS SAPIEN 3 SYSTEM in patients with severe haemodynamical valve deterioration of a biological aortic valve implanted surgically
Locations (9)
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario de La Paz
Madrid, Spain
Hospital Universitario Puerta De Hierro
Majadahonda, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, Spain
Hospital Universitari I Politècnic de La Fe
Valencia, Spain
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Freeman Hospital
Newcastle, United Kingdom
Morriston Hospital, Swansea
Swansea, United Kingdom